Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06865571 administered Day 7-14; Drug: PF-06865571 administered Day 1-14; Drug: PF-05221304 administered Day 1-14; Drug: PF-05221304 administered Day 7-14

• Registration Number: NCT03534648
• Lead Sponsor: Pfizer

Brief Summary

Drug drug interaction study between PF-05221304 and PF-06865571

Detailed Description

A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Study Timeline

• Study First Submitted: 2018-04-12
• Study Start: 2018-04-19
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Primary Completion: 2018-07-16
• Study Completion: 2018-08-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-16
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Effect of PF-05221304 on PF-06865571 PK	PF-06865571 administered Day 7-14	-
Effect of PF-05221304 on PF-06865571 PK	PF-05221304 administered Day 1-14	-
Effect of PF-06865571 on PF-05221304 PK	PF-06865571 administered Day 1-14	-
Effect of PF-06865571 on PF-05221304 PK	PF-05221304 administered Day 7-14	-

Primary Outcome Measures

Name	Time	Method
Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Day 7, 0-12 hours and Day 14 0-12 hours	Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Day 7, 0-12 hours and Day 14 0-12 hours	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)	Day 7, 0-12 hours and Day 14 0-12 hours	Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Day 7, 0-12 hours and Day 14 0-12 hours	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Screening up to 28 days after last dose of study medication	Treatment-emergent AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium